GMP topical
14.01.2022
Amendment of Delegated Regulation (EU) on Safety Features
The derogation has now been extended for another three years until 31 December 2024. With this step, the supply of medicines to Cyprus, Ireland, Northern Ireland, and Malta should be guaranteed. Furthermore, it is intended to give all parties involved sufficient time to adjust their supply chains, accordingly.
An alert system has been introduced to monitor and prevent abusive access. This is to ensure, in view of the limited monitoring possibilities, that no verification of a medicine destined for these countries takes place outside the European Economic Area.
Please find more information here.
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